此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

室内环境医疗顾问在慢性过敏性肺炎治疗中的贡献 (PHSaDom)

2026年10月12日更新者：Nantes University Hospital

Hypersensitivity pneumonitis (HP) is a diffuse infiltrative pneumonitis (DIP) of immuno-allergic origin, caused by exposure to one or more antigenic substances of organic origin, in genetically predisposed individuals. It can take a fibrosing form, eventually leading to chronic respiratory failure. Diagnosis is based on a combination of clinical, biological, CT scan and histological evidence, and is made during multidisciplinary discussions (MDD) of diffuse interstitial lung disease.

The antigens responsible, of domestic or professional origin, may be micro-organisms, animal proteins or chemical agents. However, the antigen remains unknown in almost 50% of cases. Lack of antigen identification is an independent risk factor for death in patients with fibrosing HP. In fibrosing forms, corticosteroid therapy does not appear to improve functional prognosis, and ninedanib, an antifibrosing treatment offered in progressive forms, only slows functional decline. Identifying the causative antigen is therefore an essential element in the overall management of these patients, with the aim of implementing avoidance measures. A medical exposure questionnaire has been translated into French to help physicians identify the antigen.

The serum precipitin assay is a tool developed to help identify sensitization to an antigen. It is all the more useful when investigations are targeted at the patient's suspected exposure. However, their sensitivity and specificity are variable.

The activity of the indoor environment medical advisor (CMEI) has developed in the care of patients with chronic respiratory or allergic pathologies. Their role is to carry out an audit of the dwelling, take environmental measurements to assess the health risk, inform patients about appropriate eviction measures and, in some cases, refer patients to organizations specializing in home improvement.

The CMEI visits the patient's home. The environmental audit includes a rigorous macroscopic examination and microbiological swabs of visible anomalies. The CMEI can also supplement its analysis with electrostatic dust collectors, which are left in the home for 4 weeks, enabling both qualitative and quantitative characterization of antigens.

To date, no study has prospectively evaluated the contribution of CMEI to antigen identification in patients with fibrosing HP. At the Nantes University Hospital and Angers University Hospital, the environmental audit carried out by the CMEI is an integral part of routine patient management in the event of a HP diagnosis.

The main objective of this study is to measure the diagnostic contribution of the indoor environment medical advisor in the identification of antigens responsible for respiratory pathology in patients with fibrosing HP.

研究概览

地位

招聘中

条件

过敏性肺炎

详细说明

Patients will be prospectively recruited as incidental cases during multidisciplinary discussions of diffuse interstitial lung disease organized on a regular monthly basis between university hospitals, private lung specialists and those practising in outlying hospitals.

Once the patient's non-objection has been collected, a medical self-exposure questionnaire will be completed, and the antigens identified by the questionnaire will be listed (time T1).

As in current practice, the indoor environment medical advisor (CMEI) will then visit the patient's home to carry out an environmental audit, including a macroscopic assessment and swabbing for any abnormalities that might suggest risky antigenic exposure. The results of the swab analysis will be collected along with a number of antigens (T2 time). During this visit, a sensor will be placed in the patient's home for a period of 4 weeks, and the results will be collected after 4 weeks in the home with a number of antigens (time T3).

Following these 3 evaluation times, serum precipitins will be collected according to the antigens identified during the 3 visits.

As part of the patient follow-up, a telephone call by the CMEI at 6 months from the initial environmental audit will assess whether eviction of the identified antigens has been effective. Similarly, at 12 months, the CMEI will make another home visit to assess the rate of eviction of the antigens identified at the initial visit.

In parallel, as part of routine care, a clinical and functional evaluation will be carried out at diagnosis, 6 months and 12 months. A radiological assessment involving a chest CT scan will be performed at diagnosis and at 12 months.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Stéphanie DIROU, PH
电话号码：+33 2 53 48 27 74
邮箱：stéphanie.dirou@chu-nantes.fr

研究联系人备份

姓名：François Xavier BLANC, PU PH
电话号码：+33 2 40 16 52 36
邮箱：xavier.blanc@chu-nantes.fr

学习地点

法国
- - Ancenis、法国
    - 尚未招聘
    - CH Ancenis
    - 接触：
      
      Carole HERVE
      
      电话号码：+33 2.44 76 85 06
    - 首席研究员：
      
      Carole HERVE
  - Angers、法国
    - 招聘中
    - CHU Angers
    - 首席研究员：
      
      Frédéric GAGNADOUX
    - 接触：
      
      Frédéric GAGNADOUX
      
      电话号码：+33 2 41 35 36 95
      
      邮箱：frederic.gagnadoux@chu-angers.fr
  - Châteaubriant、法国
    - 尚未招聘
    - CH Chateaubriant
    - 首席研究员：
      
      Arnaud CAVAILLES
    - 接触：
      
      Arnaud CAVAILLES
      
      电话号码：+33 2 40 16 56 77
      
      邮箱：arnaud.cavailles@chu-nantes.fr
  - La Roche-sur-Yon、法国
    - 招聘中
    - CHD LRSY
    - 接触：
      
      Cyril GUIBERT
      
      电话号码：+33 2 51 44 61 61
      
      邮箱：cyril.guibert@chd-vendee.fr
    - 首席研究员：
      
      Cyril GUIBERT
  - Les Sables-d'Olonne、法国
    - 招聘中
    - CH Cote de lumière
    - 接触：
      
      Christine BEUCHARD
      
      电话号码：+33 2 51 21 86 67
      
      邮箱：christine.beuchard@ch-cotedelumiere.fr
    - 首席研究员：
      
      Christine BEUCHARD
  - Saint-Nazaire、法国
    - 招聘中
    - CH St Nazaire
    - 接触：
      
      Judith PROVOOST
      
      电话号码：+33 2 72 27 82 59
      
      邮箱：j.provoost@ch-saintnazaire.fr
    - 首席研究员：
      
      Judith PROVOOST
- Loire-Atlantique
  - Nantes、Loire-Atlantique、法国、44093
    - 招聘中
    - CHU de Nantes
    - 首席研究员：
      
      Stéphanie DIROU
    - 接触：
      
      Stéphanie DIROU, PH
      
      邮箱：stéphanie.dirou@chu-nantes.fr
    - 副研究员：
      
      François Xavier BLANC
    - 副研究员：
      
      Charlotte MENIGOZ

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients will be prospectively recruited as incidental cases during multidisciplinary discussions of diffuse interstitial lung disease (Diffuse Interstitial Lung Disease) organized on a regular monthly basis between hospital-university centers, private lung specialists and those practising in outlying hospitals.

描述

Inclusion Criteria:

Patient of legal age,
French-speaking patient,
Patient with a diagnosis of fibrosing PHS following a multidisciplinary discussion of diffuse interstitial lung disease hypersensitivity pneumonitis .
Patient who had received an information note presenting the study and who had not expressed opposition to participating in this research.

Exclusion Criteria:

Opposition of the patient to participate in the study,
Patient under guardianship, curatorship or safeguard of justice,
Patients who have moved within the last 12 months, or who plan to move within the next 6 months,
Patients who have already had a visit from the indoor environment medical advisor.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：CASE_ONLY
时间观点：PROSPECTIVE

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
To measure the diagnostic contribution of the indoor environment medical advisor in the identification of antigens responsible for respiratory pathology in patients with fibrosing hypersensitivity pneumonitis 大体时间：1 month	Difference in the number of hypersensitivity pneumonitis (HP) risk antigens identified on the one hand by the medical exposure questionnaire and on the other by the indoor environment medical consultant in subjects with HP.	1 month

次要结果测量

结果测量	大体时间
测量静电灰尘传感器在纤维化过敏性肺炎患者抗原识别中的诊断贡献大体时间：12个月	12个月
量化使用医疗暴露调查问卷识别的抗原数量、环境医疗顾问识别的抗原数量以及使用静电传感器识别的抗原数量大体时间：1个月	1个月
以适合发现的暴露的方式测量收集的血清沉淀素的阳性率大体时间：6个月	6个月
测量环境医疗顾问访问后 6 个月和 12 个月驱逐建议的应用情况以及先前识别的抗原的驱逐率大体时间：12个月	12个月
在环境医疗顾问评估后 6 个月评估纤维化 PHS 患者的临床演变大体时间：6个月	6个月
在环境医疗顾问评估后 12 个月评估纤维化 PHS 患者的临床演变大体时间：12个月	12个月
在环境医疗顾问评估后 6 个月评估纤维化 PHS 患者的功能演变大体时间：6个月	6个月
在环境医疗顾问评估后 12 个月评估纤维化 PHS 患者的功能演变大体时间：12个月	12个月
评估环境医疗顾问评估后 6 个月时纤维化 PHS 患者的扫描演变情况大体时间：6个月	6个月
评估环境医疗顾问评估后 12 个月时纤维化 PHS 患者的扫描演变情况大体时间：12个月	12个月

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nantes University Hospital

调查人员

首席研究员：Stéphanie DIROU, PH、Nantes University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年11月16日

初级完成 (估计的)

2027年5月16日

研究完成 (估计的)

2028年5月16日

研究注册日期

首次提交

2023年8月4日

首先提交符合 QC 标准的

2023年8月4日

首次发布 (实际的)

2023年8月14日

研究记录更新

最后更新发布 (实际的)

2026年10月16日

上次提交的符合 QC 标准的更新

2026年10月12日

最后验证

2026年9月1日